Actively Recruiting
A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
Led by Elevara Medicines Limited · Updated on 2026-04-23
180
Participants Needed
29
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2 randomized, double-blind, placebo-controlled study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled. The number of participants can be extended to maximally 220 to account for dropouts during the study.
CONDITIONS
Official Title
A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and can follow the study protocol
- Male or female aged 18 to 75 years at consent
- Body mass index between 18.5 and 32.0 kg/m2 and weight at least 50 kg at screening
- Diagnosed with adult onset rheumatoid arthritis meeting 2010 ACR/EULAR criteria for at least 6 months prior to screening
- Active rheumatoid arthritis with DAS28-CRP �3.2 and at least 3 swollen and 3 tender joints at screening and baseline
- C-reactive protein above the upper limit of normal at screening
- Adequate blood, liver, and kidney function at screening and baseline
- Currently treated with methotrexate (minimum dose 7.5 mg/week if intolerant, otherwise 15-25 mg/week) for at least 6 months with stable dose for at least 3 months
- Currently treated with a tumor necrosis factor inhibitor for at least 6 months with stable dose for at least 3 months and showing partial response
- Stable doses of hydroxychloroquine (up to 400 mg/day) and oral prednisone (up to 7.5 mg daily) allowed if stable for at least 4 weeks prior to screening
- Prior treatment with other disease-modifying drugs allowed if stopped at least 2 months prior to screening; cell depleting therapies stopped at least 12 months prior
- Females of childbearing potential must have negative pregnancy tests and use effective contraception from consent until 90 days after last dose
- Male participants must use condoms and partners must use effective contraception until 90 days after last dose; no sperm donation until 90 days after last dose
You will not qualify if you...
- Class IV rheumatoid arthritis
- Treated with more than one previous biologic or targeted synthetic disease-modifying drug, excluding current tumor necrosis factor inhibitor
- Secondary non-response to tumor necrosis factor inhibitor due to anti-drug antibodies
- Dose changes in methotrexate or tumor necrosis factor inhibitor within 3 months before baseline
- Dose changes in hydroxychloroquine or oral prednisolone within 4 weeks before baseline
- Oral prednisone over 7.5 mg/day or recent parenteral corticosteroids within 4 weeks before baseline
- Recent intra-articular corticosteroids within 4 weeks before baseline
- Use of other disease-modifying or immunosuppressive drugs within 2 months before baseline
- Cell depletion therapy within 12 months before baseline
- Abnormal ECG findings including prolonged QTc, atrioventricular block, arrhythmia at screening or baseline
- Evidence or history of interstitial lung disease
- Conditions interfering with drug absorption
- Significant concurrent medical conditions that may interfere with treatment or study participation
- History of alcohol or drug abuse within 1 year before screening
- History of malignant disease except certain skin cancers without metastasis for 3 years
- Recent surgery within 12 weeks prior to screening or planned surgery during study
- Recent or planned live vaccinations
- Recent serious, opportunistic, chronic, or recurring infections within 3 months before screening
- Current infections with HIV, hepatitis B or C, or active tuberculosis
- Untreated latent tuberculosis infection
- Recent or current acute infections or fever at screening or baseline
- Other severe uncontrolled medical, surgical, psychiatric, or social conditions
- Use of other investigational drugs within 12 weeks before study drug administration
- Pregnant or breastfeeding women or those planning pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Arizona Arthritis & Rheumatology Associates
Gilbert, Arizona, United States, 85032
Actively Recruiting
2
Arizona Arthritis & Rheumatology Associates
Glendale, Arizona, United States, 85306
Actively Recruiting
3
Arizona Arthritis & Rheumatology Associates
Tucson, Arizona, United States, 85704
Actively Recruiting
4
Solace Clinical Research - Populace Health (Network)
Tustin, California, United States, 92780
Actively Recruiting
5
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
Actively Recruiting
6
Rheumatology Associates of South Florida-Clinical Research Inc - Cliniverse Research (Network)
Boca Raton, Florida, United States, 33486
Actively Recruiting
7
Prophase, LLC - Clinitiative Health Research (Network)
Margate, Florida, United States, 33063
Actively Recruiting
8
Millennium Medical Research LLC - Clinitiative Health Research (Network)
Miami, Florida, United States, 33126
Actively Recruiting
9
Floridian Clinical Research, LLC - Clinitiative Health Research (Network)
Miami Beach, Florida, United States, 33016
Actively Recruiting
10
Bioresearch Partner - Cliniverse Research (Network)
South Miami, Florida, United States, 33143
Actively Recruiting
11
Accurate Clinical Research Inc (SMO/ Network)
Lake Charles, Louisiana, United States, 70605
Actively Recruiting
12
Great Lakes Center of Rheumatology
Lansing, Michigan, United States, 48911
Actively Recruiting
13
DJL Clinical Research PLLC (Network) cIRB
Charlotte, North Carolina, United States, 28262
Actively Recruiting
14
Carolina Arthritis Associates - Cliniverse Research (Network)
Wilmington, North Carolina, United States, 28401
Actively Recruiting
15
Altoona Arthritis & Osteoporosis Center
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
16
Pennsylvania Regional Center for Arthritis & Osteoporosis Research
Wyomissing, Pennsylvania, United States, 19610
Actively Recruiting
17
Accurate Clinical Management, LLC. - Accurate Clinical Research Inc (SMO/ Network)
Baytown, Texas, United States, 77521
Actively Recruiting
18
Accurate Clinical Research Inc (SMO/ Network)
Houston, Texas, United States, 77089
Actively Recruiting
19
Heights Rheumatology and Aesthetics - ES Clinical Research Group Network
Jackson, Texas, United States, 11372
Actively Recruiting
20
Epic Medical Research-Red Oak
Red Oak, Texas, United States, 78666
Actively Recruiting
21
DM Clinical Research (Network)
Tomball, Texas, United States, 77375
Actively Recruiting
22
DM Clinical Research (Network)
Tomball, Texas, United States, 77377
Actively Recruiting
23
Panorama Medical Center
Panorama, Cape Town, South Africa, 7500
Actively Recruiting
24
The Arthritis Clinical Trial Centre
Pinelands, Capetown, South Africa, 7405
Actively Recruiting
25
Winelands Medical Research Centre - Somerset West (Dr Francois Bouwer INC)
Somerset West, Capetown, South Africa, 7500
Actively Recruiting
26
CRISMO Research Centre - Bertha Gxowa Hospital
Germiston, Gauteng, South Africa, 1401
Actively Recruiting
27
Netcare Jakaranda Hospital Suite 102
Pretoria, Gauteng, South Africa, 0002
Actively Recruiting
28
Netcare Umhlanga Medical Centre
Durban, KwaZulu-Natal, South Africa, 4319
Actively Recruiting
29
Winelands Medical Research Centre
Stellenbosch, Western Cape, South Africa, 7600
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here